Clinical data management

著者

    • Rondel, R. K. (Richard K.)
    • Varley, S. A. (Sheila A.)
    • Webb, C. F. (Colin F.)

書誌事項

Clinical data management

edited by R.K. Rondel, S.A. Varley, C.F. Webb

John Wiley, c1993

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内容説明・目次

内容説明

This volume covers all aspects of clinical data management, including such specialized fields as clinical trial monitoring, the audit process and regulatory requirements. The text should benefit those involved in pharmaceutical, biomedical and related research.

目次

  • Regulatory Requirements for the Registration Process
  • United States/European Guidelines
  • Impact of Clinical Trials on Data Management
  • Study Set-Up From the Data Management Perspective
  • Central Laboratories
  • Phase I Data Handling Needs
  • Computer Systems to Handle Clinical Data
  • Record Form Design
  • Coding Dictionaries
  • Data Input
  • Data Validation
  • Data Presentation
  • Quality Assurance and Clinical Data Management
  • The Use of Contract Houses
  • Future Trends.

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